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Basic Elements of Informed Consent

Robert Hood

08/13/2008 10:44 am

Researcher Help: Basic elements of informed consent required by regulation

General considerations Example: Basic elements of consentThe following paragraph includes all the basic elements of consent. Investigators are strongly encouraged to use this paragraph as their introductory paragraph when creating consent documents. (The numbers in parentheses show how each sentence corresponds to a required regulatory element listed below.)This is a research study.(1) If you take part, this tells you what to expect.(2-6) Talk to the research team if you:(7)
  • Have questions, including questions about your rights.
  • Have concerns or complaints.
  • Think you have been injured.
You can contact the research team at (555) 111-1111.(7) If you cannot reach the research team or want to talk to someone else, call the Florida Department of Health IRB. The phone number is (866) 433-2775 (toll free in Florida) or (850) 245-4585(9). Taking part is up to you. You can refuse to take part. You can join now and quit later. Either way it won't affect how we treat you.(8)
  1. 45 CFR 46.116(a)(1); 21 CFR 50.25(a)(1)
  2. 45 CFR 46.116(a)(2); 21 CFR 50.25(a)(2)
  3. 45 CFR 46.116(a)(3); 21 CFR 50.25(a)(3)
  4. 45 CFR 46.116(a)(4); 21 CFR 50.25(a)(4)
  5. 45 CFR 46.116(a)(5); 21 CFR 50.25(a)(5)
  6. 45 CFR 46.116(a)(6); 21 CFR 50.25(a)(6)
  7. 45 CFR 46.116(a)(7); 21 CFR 50.25(a)(7)
  8. 45 CFR 46.116(a)(8); 21 CFR 50.25(a)(8)
  9. DOH IRB required contact information
This paragraph contains all the required disclosures. It shows that the basic elements of consent can be communicated at less than a 6th grade level. When the DOH IRB reviews consent documents, it must consider whether the consent process and documentation of consent are understandable. Using the example above helps assure that the basic elements of consent are written that most people can understand.Background
  • Informed consent means an individual’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or undergo a diagnostic, therapeutic, or preventive procedure. Consent is the means by which researchers uphold the value of respect for persons.
  • Informed consent is an ongoing process of dialogue and discussion between the researcher and participants (See Help: Process of Consent). The researcher should explain the study and participants should have an opportunity to have their questions answered. The process of consent reflects the importance of the dialogue between researcher and participants. The process should be distinguished from the documentation of consent. The IRB needs to evaluate both the process and documentation of consent.
Some of the factors the IRB considers when evaluating the process of consent include:
  • who will seek informed consent?
  • where will the consent discussion take place?
  • will the researcher encourage the participant to discuss the research with their physician or friends and family?
  • if the study will recruit individuals who do not speak English, does the study team have the capacity to discuss the consent in another language?
Some of the factors the IRB considers when evaluating the investigator's proposed process of consent include:
  • does the consent document include all the required disclosures? (the example above includes all the required elements)
  • is the consent document written in a language that is understandable to participants? (the example above is written at a 6th grade level)
  • if participants include individuals who do not speak English, will the consent document be provided in other languages?

Required Determinations by the IRB

The IRB must determine that informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by regulation, unless the research qualifies for an alteration of the elements of consent or a waiver of documentation of consent.

Accreditation Element

Element III.1.F: The Investigator develops an informed consent process and method of documentation appropriate to the type of research and the study population, emphasizing the importance of participant comprehension and voluntary participation.

Regulations

45 CFR §46.116, 45 CFR §46.116(a)(7), 45 CFR §46.117(a), 21 CFR §50.20, 21 CFR §50.25(a)(7), 21 CFR §50.27(a), 21 CFR §50.27(b)(2)

Guidance

Reference

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